Assessment of the safety of a cell-based therapy on reducing the deterioration of kidney function in patients with kidney disease

Not Applicable

Completed

• Conditions: Chronic kidney disease; Urological and Genital Diseases; Kidney disease

• Registration Number: ISRCTN13142863
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

2017 Results article in https://pubmed.ncbi.nlm.nih.gov/28148896/ (added 15/02/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-24
• Study Completion: 2017-07-31
• Last Update Posted: 1 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Age 20–80 years old
2. Chronic kidney disease due to hypertension after optimum drug therapy
3. Chronic kidney disease, stage III–IV with stable renal function within 1 year

Exclusion Criteria

1. Younger than 20 years old or older than 80 years old
2. Pregnant or breastfeeding women
3. Infections (e.g., with human immunodeficiency virus [HIV])
4. Myocardial infarction or congestive heart failure (functional class IV) within 3 months
5. Malignancy
6. Other severe organ failure
7. Life expectancy of less than 1 year
8. End-stage renal disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with an improvement of 5 mL/min in creatinine clearance rate after CD34+ cell treatment at baseline and at 1 week, 1 month, 3 months, 6 months, 9 months and 12 months after therapy

Secondary Outcome Measures

Name	Time	Method
<br> Significant reductions in:<br> 1. Proteinuria, will be measured every day after therapy for 3 days<br> 2. Creatinine, will be measured every day after therapy for 3 days<br> 3. Combined secondary end-point, defined as acute renal failure with requirement for haemodialysis, or death, at 1 week, 1 month, 3 months, 6 months, 9 months and 12 months after therapy<br>